AML, AdultAGE-INGNCT05909501
Assessment of Geriatric Evaluations Impact on New AML Guidance
An observational study of AML, Adult, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The goal of the study is to measure physiologic age (there is no current formal definition but is meant to imply that patients should be evaluated holistically rather than on age alone) at baseline in newly diagnosed AML patients over 50 years receiving either intensive or non-intensive treatment. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- AML, Adult
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2023to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from the physician practices of Penn Medicine.
Who may be able to join
- AML diagnosis by peripheral flow cytometry and/or bone marrow aspirate and biopsy
- New diagnosis being considered for new line of treatment
- Age ≥ 50 years.
- Performance status 0,1, and 2
Who cannot join
- Inability to understand or unable to sign a written informed consent
- Unable to fill out questionnaires on their own and/or do not have someone to help complete them
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: AGE-ING (Assessment of Geriatric Evaluations Impact on New AML Guidance) Study
The goal of the study is to measure physiologic age (there is no current formal definition but is meant to imply that patients should be evaluated holistically rather than on age alone) at baseline in newly diagnosed AML patients over 50 years receiving either intensive or non-intensive treatment. This information will be used to evaluate toxicity, early mortality, remission rates and long term survival.
- Conditions
- AML, Adult
- Medical subject headings
- Leukemia, Myeloid, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate physiologic age using baseline measures of physical function, depression, cognition, frailty, and PROs in newly diagnosed AML patients receiving intensive and non-intensive treatment in relation to overall survival at 1 year.
Short physical performance battery (SPPB), geriatric depression scale (GDS), mini-COG, patient reported outcomes of physical function, fatigue, depression, cognition, anxiety
Measured: At baseline, 14 days after treatment, 1 month after treatment
Evaluate baseline measures of physiologic age in relation to short term mortality
Measured: At 30 days and 60 days
Evaluate baseline measures of physiologic age in relation to grade 3, 4, and 5 toxicities from treatment
Measured: At baseline, 14 days after treatment, 1 month after treatment
Evaluate baseline measures of physiologic age in relation to complete remission
Measured: At baseline, 14 days after treatment, 1 month after treatment
Compare baseline measurements to serial measurements to understand how physical function changes over time with treatment
Measured: At baseline, 14 days after treatment, 1 month after treatment
Evaluate albumin as a biomarker predictor of clinical outcomes of short term mortality, 1 year OS and toxicity
Measured: At 30 days and 60 days
Create a predictive pre-treatment screening tool
Measured: At baseline, 14 days after treatment, 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start25 Oct 2023
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML, AdultStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Catherine Lai, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909501
- Sponsor's protocol ID
- UPCC 11423
- Acronym
- AGE-ING
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AGE-ING (Assessment of Geriatric Evaluations Impact on New AML Guidance) Study
- ClinicalTrials.gov ID
- NCT05909501
- Acronym / sponsor ID
- AGE-ING / UPCC 11423
- Conditions
- AML, Adult
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to measure physiologic age (there is no current formal definition but is meant to imply that patients should be evaluated holistically rather than on age alone) at baseline in newly diagnosed AML patients over 50 years receiving either intensive or non-intensive treatment. This information will be used to evaluate toxicity, early mortality, remission rates and long term survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the physician practices of Penn Medicine.
Key inclusion criteria (4 listed)
- AML diagnosis by peripheral flow cytometry and/or bone marrow aspirate and biopsy
- New diagnosis being considered for new line of treatment
- Age ≥ 50 years.
- Performance status 0,1, and 2
Key exclusion criteria (2 listed)
- Inability to understand or unable to sign a written informed consent
- Unable to fill out questionnaires on their own and/or do not have someone to help complete them
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate physiologic age using baseline measures of physical function, depression, cognition, frailty, and PROs in newly diagnosed AML patients receiving intensive and non-intensive treatment in relation to overall survival at 1 year.
Time frame: At baseline, 14 days after treatment, 1 month after treatment
Short physical performance battery (SPPB), geriatric depression scale (GDS), mini-COG, patient reported outcomes of physical function, fatigue, depression, cognition, anxiety
Evaluate baseline measures of physiologic age in relation to short term mortality
Time frame: At 30 days and 60 days
Evaluate baseline measures of physiologic age in relation to grade 3, 4, and 5 toxicities from treatment
Time frame: At baseline, 14 days after treatment, 1 month after treatment
Evaluate baseline measures of physiologic age in relation to complete remission
Time frame: At baseline, 14 days after treatment, 1 month after treatment
Compare baseline measurements to serial measurements to understand how physical function changes over time with treatment
Time frame: At baseline, 14 days after treatment, 1 month after treatment
Evaluate albumin as a biomarker predictor of clinical outcomes of short term mortality, 1 year OS and toxicity
Time frame: At 30 days and 60 days
Create a predictive pre-treatment screening tool
Time frame: At baseline, 14 days after treatment, 1 month after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catherine Lai, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AML, Adult, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colleen Redlinger (2152209693, colleen.redlinger@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate physiologic age using baseline measures of physical function, depression, cognition, frailty, and PROs in newly diagnosed AML patients receiving intensive and non-intensive treatment in relation to overall survival at 1 year. (time frame: At baseline, 14 days after treatment, 1 month after treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.